Degenerative valvular disease specific annuloplasty rings

ABSTRACT

Annuloplasty rings optimally sized to take into account more of the common degenerative valve pathologies. Each ring has a structural ring body with a shape that complies with predicted shapes of degenerative valvular diseases, such as fibroelastic deficiency (FED), Marfan&#39;s or Barlow&#39;s. The predicted shapes are obtained through careful echocardiographic and intraoperative measurements, and often differ for different annulus orifice sizes. For instance, in mitral rings the larger rings have larger minor axis and oblique axis dimensions relative to their major axis dimensions, and are more circular as opposed to D-shaped. The rings may also be three-dimensional and the relative heights around the rings may change for different sized rings. A mitral ring may have a higher anterior saddle relative to a posterior saddle, with the relative heights varying across the ring sizes. The ring may have varying flexibility around the ring periphery which also changes for different ring sizes. A bulge on the sewing cuff forms a step on the outflow side for ease of suturing, which may be indicated by a suture line.

RELATED APPLICATIONS

The present application is a divisional of U.S. application Ser. No.12/209,148, filed Sep. 11, 2008, which is a continuation-in-part of U.S.application Ser. No. 12/028,714, filed Feb. 8, 2008, which in turnclaims priority under 35 U.S.C. §119(e) to U.S. Provisional ApplicationNo. 60/889,178, filed Feb. 9, 2007.

FIELD OF THE INVENTION

The present invention relates to medical devices that support andsurgically correct a heart valve experiencing valve regurgitation due todegenerative valvular disease. In particular, the present inventionpertains to annuloplasty ring prostheses, in a set of rings, the shapeof which is specifically adapted to the anatomical configuration ofvarious forms of degenerative mitral valve disease.

BACKGROUND OF THE INVENTION

The human heart has four valves; the aortic valve, the mitral valve, thepulmonary valve and the tricuspid valve. Various diseases and certaingenetic defects of the heart valves can impair their proper functioning.The common defects and diseases affecting each of these valves, and thetreatments thereof, are typically different.

As seen in FIGS. 1 and 2, the mitral valve is a two-leaflet (orbicuspid) structure of connective tissue separating the left atrium (LA)from the left ventricle (LV). The mitral valve functions to maintainblood flow in one direction, i.e., from the atrium toward the ventricleduring ventricular relaxation or diastole, while preventing back flow inthe opposite direction during ventricular contraction or systole. Thebases of the two valve leaflets are attached to a circular fibrousstructure of the heart called the annulus (AN), and their free edges tochordae tendinae arising from the papillary muscles of the leftventricle. An anterior leaflet (AL) is relatively large and attaches tothe anterior segment of the annulus, while a posterior leaflet (PL) issmaller but extends further circumferentially and attaches to theposterior segment of the annulus. The posterior leaflet presents threescallops identified as P1, P2, P3, while the corresponding non-scallopedparts of the anterior leaflet are identified as A1, A2, and A3,according to Carpentier's segmentation.

Several diseases can affect the structure and function of the mitralvalve. The mitral valve and, less frequently, the tricuspid valve, areprone to deformation and/or dilation of the valve annulus, tearing ofthe chordae tendineae and leaflet prolapse, which results in valvularinsufficiency wherein the valve does not close properly and allows forregurgitation or back flow from the left ventricle into the left atrium.Deformations in the structure or shape of the mitral or tricuspid valveare repairable.

Mitral regurgitation is one of the most common valvular malfunctions inthe adult population, and typically involves the elongation or dilationof the posterior two-thirds of the mitral valve annulus, the sectioncorresponding to the posterior leaflet. The most common etiology ofsystolic mitral regurgitation is myxomatous degeneration, also termedmitral valve prolapse (29% to 70% of cases), which afflicts about 5 to10 percent of the population in the U.S. Women are affected about twiceas often as men. Myxomatous degeneration has been diagnosed as Barlow'ssyndrome, billowing or ballooning mitral valve, floppy mitral valve,floppy-valve syndrome, prolapsing mitral leaflet syndrome, or systolicclick-murmur syndrome. The symptoms include palpitations, chest pain,syncope or dyspnea, and a mid-systolic click (with or without a latesystolic murmur of mitral regurgitation). These latter symptoms aretypically seen in patients with Barlow's syndrome, where extensivehooding and billowing of both leaflets are the rule. Some forms ofmitral valve prolapse seem to be hereditary, though the condition hasbeen associated with Marfan's syndrome, Grave's disease, and otherdisorders.

Myxomatous degeneration involves weakness in the leaflet structure,leading to thinning of the tissue and loss of coaptation. Barlow'sdisease is characterized by myxoid degeneration and appears early inlife, often before the age of fifty. In Barlow's disease, one or bothleaflets of the mitral valve protrude into the left atrium during thesystolic phase of ventricular contraction. The valve leaflets are thickwith considerable excess tissue, producing an undulating pattern at thefree edges of the leaflets. The chordae are thickened, elongated and maybe ruptured. Papillary muscles are occasionally elongated. The annulusis dilated and sometimes calcified. Some of these symptoms are presentin other pathologies as well and, therefore, the present applicationwill refer to myxoid degeneration, which is the common pathologicfeature of the various diagnoses, including Barlow's syndrome.

Other causes of mitral regurgitation include ischemic heart disease withischemic mitral regurgitation (IMR), dilated cardiomyopathy (in whichthe term “functional mitral regurgitation” [FMR] is used), rheumaticvalve disease, mitral annular calcification, infective endocarditis,fibroelastic deficiency (FED), congenital anomalies, endocardialfibrosis, and collagen-vascular disorders. IMR is a specific subset ofFMR, but both are usually associated with morphologically normal mitralleaflets. Thus, the types of valve disease that lead to regurgitationare varied and present vastly differently.

A number of these disease states have been schematically illustrated inFIGS. 4-8 with FIGS. 3A and 3B illustrating a normal mitral valve inplan and schematic sectional views across the anterior and posteriorleaflets. FIGS. 4A and 4B show a mitral valve, also in plan andschematic sectional views, where the annulus is dilated and deformedcausing mitral regurgitation. FIGS. 5A and 5B illustrate mitral valveswith ruptured and elongated chordae, both causing mitral regurgitation.FIGS. 6A and 6B show symptoms of Barlow's disease with excess tissue andirregularly thickened leaflets. Barlow's disease is seen most often inthe young population and has a long-lasting evolution before the onsetof valve regurgitation. FIGS. 7A and 7B are views of a mitral valvehaving fibro-elastic deficiency with thinned leaflets and with excesstissue. Fibro-elastic deficiency, first described by Carpentier, isusually seen in more elderly people, and has a short-lasting evolutionbefore valve regurgitation. The anatomical characteristics include amoderately enlarged kidney-shaped valvular orifice without excessleaflet tissue. The leaflet tissue displays a degeneration of thefibro-elastic bundles. Finally, FIGS. 8A and 8B illustrate themorphology of a mitral valve in Marfan's disease with excess and thintissue and elongated chordae. Marfan's is a genetic disorder seen at anyage. It has a long-lasting evolution before the onset of regurgitation.The annulus is severely dilated and deformed, the chordae are elongated,and the leaflets are thin and degenerative.

As is clear from the illustrations of FIGS. 4-8, many conditions lead toregurgitation. At a structural level, four general types of structuralchanges of the mitral valve apparatus can cause regurgitation: leafletretraction from fibrosis and calcification, annular dilation, chordalabnormalities (including rupture, elongation, shortening, or apicaltethering or “tenting” as seen in FMR and IMR), and possibly papillarymuscle dysfunction.

Another approach to characterizing mitral valve disease is Carpentier'sfunctional classification of the types of leaflet and chordal motionassociated with mitral regurgitation. This is illustrated in FIGS.9A-9D, which show anatomical positions during left ventricular systoliccontraction when the leaflets of the mitral valve close or coapt. InType I, FIG. 9A, excess dilatation of the annulus (seen in dashedoutline) results in lack of coaptation between otherwise normalleaflets. Type II (seen in FIG. 9B) mitral regurgitation is due toleaflet prolapse or excessive motion because of rupture or elongation ofthe chordae tendinae. Type III involves restricted or tethered leafletmotion, classed as occurring during diastole Type IIIa (FIG. 9C) orduring systole Type IIIb (FIG. 9D). Type IIIb (FIG. 9C) is typicallyseen in patients with ischemic mitral regurgitation. The course of theleaflets during the cardiac cycle is represented by the dotted lines.(Derived from Carpentier A: Cardiac valve surgery: the “Frenchcorrection.” J Thorac Cardiovasc Surg 86: 323, 1983.)

Various surgical techniques may be used to repair diseased or damagedmitral and tricuspid valves. These include but are not limited toannuloplasty (i.e., contracting the valve annulus to restore the propersize and shape of the valve), quadrangular resection of the leaflets(i.e., removing tissue from enlarged or misshapen leaflets),commissurotomy (i.e., cutting the valve commissures to separate thevalve leaflets), shortening and transposition of the chordae tendoneae,reattachment of severed chordae tendoneae or papillary muscle tissue,and decalcification of valve and annulus tissue.

In patients with degenerative mitral valve disease, valve repair usingmitral valvuloplasty valve reconstruction, remodeling, or annuloplastyhas been the standard for surgical correction of mitral regurgitationand has provided good long-term results. A rigid support ring (e.g.,Carpentier-Edwards Classic® Annuloplasty Ring), a semi-flexible ring(e.g., Carpentier-Edwards Physio® Annuloplasty Ring), or a flexiblecurved band (e.g., Cosgrove-Edwards® Annuloplasty System) may be used.Closed rings are typically D- or kidney-shaped and generally exhibit aminor/major axis ratio of about 3:4. Some rings are flat or planar,while others exhibit three-dimensional bows. The rings are sutured tothe deformed annulus so as to theoretically restore its normal shape andsize and restore apposition of the leaflets. It should be noted that notall physicians agree which ring is appropriate for any one condition.

For illustration of conventional treatment, FIG. 10A is a surgeon's orplan view of a mitral valve having a deformed annulus leading toregurgitation. For decades, a suitable method of correcting such adeformed mitral valve annulus was to implant a prosthetic annuloplastyring to restore normal apposition of the leaflets. FIG. 10B shows theannulus after implantation of a Carpentier-Edwards Physio® semi-flexibleannuloplasty ring, the most frequently used ring in these cases,although a similar correction can be performed using other rings, suchas those described in FIGS. 12-14. The aim of a conventionalannuloplasty ring (and conventional wisdom) is to restore the shape ofthe normal mitral annulus, or, in some conditions, to overcorrect theshape by pulling inward a segment of the annulus. Unfortunately, theattachment of an annuloplasty ring sometimes leads to unintendedconsequences, as explained below. ← Dr. Carpentier, your discussion ofthe drawback of conventional ring repair with resulting SAM was includedin paragraph [0066] with reference to FIGS. 10B and 11A-11C. We do notwant to place that discussion here because though you have recognizedthis, we have no information that it is common knowledge. So, placingthat discussion below as opposed to here in the background is preferredfrom a legal standpoint. Even if it was well known, putting it herecould telegraph the solution.

Despite accepted treatments for correcting mitral regurgitation, thereis a need for a simpler and more effective approach that takes intoaccount more of the common pathologies.

SUMMARY OF THE INVENTION

Annuloplasty rings designed to restore the specific morphology anddynamic characteristics of heart valves damaged by various degenerativevalvular disease to overcome some of the limitations of currentlyavailable rings is described. For instance, despite satisfactory resultsover the years with the currently available Carpentier-Edwards Physio®ring, rings described here better meet the need for treatingdegenerative valvular diseases.

The annuloplasty rings will take into account the effects ofdegenerative valvular diseases over various heart valve sizes andoptimize:

the ring shape and dimensions,

the saddle shape configuration,

the ring flexibility,

the sewing cuff of the ring, and

the method of ring selection.

For patients suffering from degenerative valvular diseases, the use ofcurrently available rings to either restore the shape of a normal mitralvalve annulus, or overcorrect the annular shape by pulling inward asegment of the annulus yields sub-optimal results. It has beendiscovered that an optimal technique to correct mitral valve dysfunctionin degenerative valvular diseases is to restore the peculiar (abnormal)shape of the annulus characteristic of each type of valvular disease.Furthermore, the ratio between the antero-posterior diameter and thetransverse diameter in prior rings is not appropriate for the peculiarring configuration needed in degenerative valvular disease. Annuloplastyrings are designed taking into account such important characteristics asthe overall shape of the annulus, the dimensions in the differentorientations, and the curvature of the different segments of theannulus. The global morphology of the annulus of a heart valve affectedby degenerative valvular diseases is assessed by metrology, imagingtechniques, and intra-operative measurements. Mathematical models havebeen used to design optimal shapes and size characteristics of the ringsets.

A method of implanting an annuloplasty ring described herein thereforeincludes assessing the characteristic shape of an annulus of a heartvalve afflicted by degenerative valvular disease. The “characteristicshape” of such an annulus includes both its size and three-dimensionalshape, and may be obtained by direct or indirect measurements of theparticular patient, or by a combination of measurements and anunderstanding of the morphological characteristic of different diseasestates. The characteristic shape depends, inter alia, on the nature ofthe valvular disease and the valve size. In general, the shape becomesmore circular as the ring size increases, and conversely becomes morekidney-shaped as the ring size decreases. For example, a number ofdisease states have been schematically illustrated in FIGS. 4-8,representing the most common pathologies of these diseases. The surgeonmay also take into account Carpentier's functional classification of thetypes of leaflet and chordal motion associated with mitralregurgitation, as illustrated in FIGS. 9A-9D. Other sources consideredauthoritative in describing characteristic shapes of diseased mitralannuluses include A. Carpentier, et al.: J Thorac Cardiovasc Surg 79:338, 1980, and A. Carpentier: Cardiac valve surgery: the “Frenchcorrection.” J Thorac Cardiovasc Surg 86: 323, 1983. The surgeon thenreferences the characteristic shape of the annulus of a heart valve forthe particular annulus size and degenerative heart valve disease, andselects an annuloplasty ring that corresponds to that annulus size andshape. In other words, rather than trying to constrict the diseasedannulus, or otherwise conform the annulus to a “normal” shape, the goalis to fit the ring to the shape of the annulus that is characteristic ofthe disease that afflicts the valve being treated.

Similarly, it has been discovered that previous annuloplasty ringshaving a saddle or upward bulge in the anterior sections may not beoptimal in the case of degenerative valvular disease. In particular,prior rings can suffer from ring dehiscence at the commissural segments.The saddle shape of ring sets set forth here are, therefore, optimizedto conform to specific morphologies and structures of the differentdegenerative valvular diseases. Again, saddle shape optimization hasbeen obtained from imaging techniques and intra-operative valveanalyses. In addition to an increase in the pre-existing upward bow inthe anterior section, a posterior bow has been emphasized. The doublebow configuration provides a more compliant structure, particularly atthe commissures.

A method of implanting an annuloplasty ring at a patient's valve annulusafflicted by a degenerative heart valve disease is disclosed herein. Themethod includes measuring the size of the valve annulus, and referencingthe characteristic shape of the annulus of a heart valve afflicted bythe degenerative heart valve disease. An annuloplasty ring is selectedhaving a size and shape that corresponds to the characteristic shape ofthe degenerative heart valve disease for that annulus size. Finally, thesurgeon implants the selected annuloplasty ring at the patient's valveannulus.

In the preceding method, the step of referencing may compriseechocardiographic and intraoperative measurements of the patient's valveannulus. Where the patient's valve annulus is the mitral valve annulus,the measurements typically include transverse diameter, antero-posteriordiameter, and at least three oblique dimensions extending from thegeometric center of the annulus to the posterior aspect of the annulus.The degenerative heart valve disease may manifest as mitral valveregurgitation.

A method of manufacturing an annuloplasty ring is disclosed herein andcomprises first referencing the characteristic shape of the annulus of aheart valve afflicted by a degenerative heart valve disease. Next, anannuloplasty ring is formed with a size and shape that corresponds tothe characteristic shape of the annulus. The characteristic shape may beobtained partly by echocardiographic and intraoperative measurements ofan afflicted annulus. For instance, where the patient's valve annulus isthe mitral valve annulus, the measurements may include transversediameter, antero-posterior diameter, and at least three obliquedimensions extending from the geometric center of the annulus to theposterior aspect of the annulus. The degenerative heart valve diseasemay manifest as mitral valve regurgitation.

The present application also describes a mitral annuloplasty ring forcorrecting a patient's mitral valve annulus afflicted by a degenerativeheart valve disease. The ring has a ring body defining a periphery withan anterior segment opposite a posterior segment, and two side segments.The ring body has a size and shape that corresponds to thecharacteristic shape of the heart valve afflicted by the degenerativeheart valve disease for that annulus size. The characteristic shape ofthe annulus of the heart valve afflicted by the degenerative heart valvedisease may be obtained partly by echocardiographic and intraoperativemeasurements of an afflicted annulus. Where the patient's valve annulusis the mitral valve annulus, the measurements may typically includetransverse diameter, antero-posterior diameter, and one or more,preferably three, oblique dimensions extending from the central axis ofthe annulus to the posterior aspect of the annulus. The degenerativeheart valve disease may manifest as mitral valve regurgitation.

In the preceding rings and methods of forming, and where the patient'svalve annulus is the mitral valve annulus, the ring typically defines amajor axis and a minor axis and may be selected to have a size and shapesymmetric about the minor axis that preserves or restores full leafletmobility to the patient's mitral valve. Preferably, the size and shapeof the ring as proposed herein addresses the problems of excess tissueand related valve dysfunction commonly seen in degenerative valvulardiseases. In one example, for rings having a size of 34 mm or larger,the size and shape of the ring conforms to the abnormal annulus shape ofBarlow's disease, rather than a normal shape.

Where the patient's valve annulus is the mitral valve annulus, the ringtypically defines an anterior segment opposite a posterior segment, andtwo side segments, and may have varying flexibility around its peripherywith the posterior segment being more flexible than the anteriorsegment. In a preferred embodiment, the ring generally defines a D-shapein plan view with a relatively straight anterior segment opposite acurved posterior segment, and for rings having a size of 34 mm or largerthe D-shape diminishes and becomes generally more circular. In anotherembodiment, the ring is three-dimensional with the center of theanterior segment rising to a height C and the center of the posteriorsegment rising to height D above a common datum plane, wherein the ratioC/D>1, preferably about 3:1

The present application also discloses a mitral annuloplasty ring, ormethod of forming such a ring, comprising a ring body defining aperiphery with an anterior segment opposite a posterior segment, and twoside segments, wherein the periphery is defined in plan view by fourcircular arcs, one for each segment, connected at points of tangency.Preferably, the ring defines a horizontal line segment a1-a2 having alength A along the major axis of the ring. Two of the four circular arcsdefining the ring body periphery consist of portions of two congruentcircles c2, c3 that include points a1 and a2, respectively, and bothhave a center along line segment a1-a2 and include a point b1 at thecenter of line segment a1-a2.

The mitral annuloplasty ring may further define a vertical line segmentb1-b2 extending from center point b1 and having a length B′=(0.3125·A),a vertical line segment b1-b3 opposite b1-b2, wherein the line segmentb2-b3 defines the minor axis of the ring and has a length B. A third oneof the four circular arcs defining the ring body periphery consists ofan arc T1-T4 that is tangent at both ends to the outer circles c2 and c3and includes point b2, and a fourth one of the four circular arcsdefining the ring body periphery consists of an arc T2-T3 that istangent at both ends to the outer circles c2 and c3 and includes pointb3. Desirably, the lengths A and B of the ring body are selected fromthe groups consisting of:

-   -   A is 34 mm, B is about 23.5 mm;    -   A is 36 mm, B is about 25.5 mm;    -   A is 38 mm, B is about 27.2 mm; and    -   A is 40 mm, B is about 28.7 mm.

A mitral annuloplasty ring defined herein has a ring body defining aperiphery with an anterior segment opposite a posterior segment, and twoside segments. The ring body in plan view defines a major axis A and aminor axis B extending across from the anterior segment to the posteriorsegment. The dimensional pairs B and A are selected from the groupsconsisting of:

-   -   A is about 34 mm and B is about 23.5 mm;    -   A is about 36 mm and B is about 25.5 mm;    -   A is about 38 mm and B is about 27.2 mm; and    -   A is about 40 mm and B is about 28.7 mm.

In the aforementioned mitral annuloplasty ring, the ratio of B/A ispreferably greater than or equal to 0.69 and less than or equal to 0.73.Furthermore, the axial elevation of the anterior segment is preferablyhigher than the axial elevation of the posterior segment. In oneembodiment, the ring body generally defines a D-shape in plan view witha relatively straight anterior segment opposite a curved posteriorsegment, and as the ring size increases the D-shape diminishes andbecomes generally more circular.

Another mitral annuloplasty ring defined herein comprise a ring bodydefining a periphery with an anterior segment opposite a posteriorsegment, and two side segments, the ring body in plan view defining amajor axis A and a minor axis B extending across from the anteriorsegment to the posterior segment, wherein A is about 34 mm and B isabout 23.5 mm. In a similar ring, A is about 36 mm and B is about 25.5mm, or A is about 38 mm and B is about 27.2 mm, or A is about 40 mm andB is about 28.7 mm. Desirably, the ring body is also three-dimensionalwith the center of the anterior segment rising to a height C and thecenter of the posterior segment rising to height D above a common datumplane, wherein the ratio C/D>1, preferably about 3:1.

Another method of manufacturing mitral annuloplasty rings disclosedherein includes forming mitral annuloplasty rings of different sizeswhere each ring has a ring body defining a periphery with an anteriorsegment opposite a posterior segment, and two side segments. Each ringbody in plan view defines a major axis dimension A and a minor axisdimension B extending across from the anterior segment to the posteriorsegment, and each ring has an identified orifice size. The ring bodiesin plan view approximate a D-shape for smaller ring sizes and havegradually more circular shapes for larger ring sizes. Desirably, themethod includes forming the ring body to be three-dimensional with thecenter of the anterior segment rising to a height C and the center ofthe posterior segment rising to height D above a common datum plane,wherein the ratio C/D>1, preferably about 3:1. The shapes of the ringbodies in plan view for different orifice sizes preferably change tocomply with predicted shapes of degenerative valvular disease fordifferent annulus orifice sizes. In one example, the ratio B/A for eachring body increases with increasing ring orifice size.

In accordance with another embodiment, ring sets comprise two upwardbows on both the anterior and posterior sections of the ring bodies.Desirably, the anterior bow is more pronounced than the posterior bow soas to adapt to the specific configuration of the mitral annulus. Forinstance, the anterior section may bow upward between 2-8 mm, preferablybetween 3-6 mm. In one embodiment, the anterior bow in a set ofannuloplasty rings changes across ring sizes to take into account thetendency of the annulus of degenerative valves to flatten as the annulusdilates. The posterior bow desirably varies between 0.5-4 mm, andpreferably between 0.5-2 mm. Again, the relative posterior bow typicallyflattens for larger annulus sizes.

The set of annuloplasty rings for correcting a heart valve annulus,comprises a set of rings each having a ring body able to resistdeformation when subjected to the stress imparted thereon by the valveannulus. The ring bodies are each arranged around a flow axis having anupward direction and a downward direction, the downward directioncorresponding to the direction of blood flow through the valve annuluswhen the annuloplasty ring is implanted. Each ring has an identifiedorifice size and the proportional shapes of the ring bodies change withincreasing orifice sizes of the rings in the set. The annuloplasty ringsmay be configured for implantation in various positions, including themitral and tricuspid positions. The annuloplasty rings are desirablyconfigured for implantation in the mitral position and smaller rings inthe set generally define a D-shape in plan view with a relativelystraight anterior segment opposite a curved posterior segment, and asthe orifice sizes of the rings become larger the D-shape diminishes andbecomes generally more circular. Furthermore, the ring bodies arepreferably three-dimensional with the center of the anterior segmentrising to a height C and the center of the posterior segment rising toheight D above a common datum plane, wherein the ratio C/D>1.Preferably, the ratio C/D is about 3:1, and the height C of the anteriorsegment rises up to at least 6 mm above the common datum plane. In apreferred embodiment the change in proportional shapes of the ringbodies is a change in the ratio of the heights C and D of the oppositesides.

In one particularly useful embodiment, the proportional shapes of thering bodies change to comply with the characteristic shapes of aparticular valvular disease for different annulus orifice sizes. Thecharacteristic shapes of a particular valvular disease may be calculatedfrom echocardiographic and intraoperative measurements. For instance, ifthe annuloplasty rings are configured for implantation in the mitralposition and have an anterior segment opposite a posterior segment, themeasurements include transverse diameter, antero-posterior diameter, andat least three oblique dimensions extending from a central axis of theannulus to the posterior aspect of the annulus.

In another aspect, a set of mitral annuloplasty rings each comprises aring body able to resist deformation when subjected to the stressimparted thereon by the mitral valve annulus and arranged around a flowaxis having an upward direction and a downward direction. The downwarddirection corresponds to the direction of blood flow through the mitralvalve annulus when the annuloplasty ring is implanted. In accordancewith a preferred embodiment, each ring body defines in plan view a majoraxis A and a minor axis B extending across from an anterior segment to aposterior segment, and each ring has an identified orifice size. In planview, as seen along the flow axis, the ring bodies in a set of ringsdefines different proportional shapes depending on the type ofdegenerative valvular disease in the size of the ring. The proportionalshapes of the ring bodies change with increasing orifice sizes of therings in the set. For instance, the ratio B/A for each ring bodyincreases with increasing orifice sizes of the rings in the set. In thelatter case, the ring bodies will have a more pronounced circular shapein the larger sizes and more pronounced kidney or D-shapes in thesmaller sizes. The set of rings is optimally sized to take into accountmore of the common pathologies. The ring bodies may also have varyingflexibility around their peripheries, wherein the relative flexibilitybetween the anterior segment and the posterior segment changes withincreasing ring orifice size. Desirably, each ring further includes asuture-permeable covering over the ring body, and the covering has asmooth relatively flat inflow side and a stepped outflow side.

In a still further aspect a set of mitral annuloplasty rings eachcomprises a ring body able to resist deformation when subjected to thestress imparted thereon by the mitral valve annulus and arranged arounda flow axis having an upward direction and a downward direction. Thedownward direction corresponds to the direction of blood flow throughthe mitral valve annulus when the annuloplasty ring is implanted. Eachring has an identified orifice size, and each ring body in plan viewdefines a major axis A and a minor axis B extending across from ananterior segment to a posterior segment, the ratio B/A for the ringbodies changing with increasing ring orifice size. The ring bodies arepreferably D-shaped in plan view with a relatively straight anteriorsegment opposite a curved posterior segment, wherein the shape of thering bodies is a more pronounced D-shape for smaller rings and becomesgradually more circular with increasing ring orifice size. The ringbodies may also be three-dimensional with the center of the anteriorsegment rising to a height C and the center of the posterior segmentrising to height D above a common datum plane, and wherein the ratio C/Dchanges with increasing ring orifice size. Desirably, each ring furtherincludes a suture-permeable covering over the ring body, and thecovering has a smooth relatively flat inflow side and a stepped outflowside. The ring bodies each define a continuous or discontinuousperiphery.

BRIEF DESCRIPTION OF THE DRAWINGS

Features and advantages of the devices and methods disclosed herein canbe understood with reference to the specification, claims, and appendeddrawings wherein:

FIG. 1 is a cross-sectional view of the left side of the human heartshowing the left atrium (LA) separated from the aorta (Ao) by the mitralvalve;

FIG. 2 is a surgeon's or plan view of a normal mitral valve in theclosed position illustrating the anterior leaflet (AL) and the posteriorleaflet (PL) attached to the annulus (AN), and indicating eightidentifiable leaflet segments;

FIGS. 3A and 3B illustrate a normal mitral valve in plan and schematicsectional views across the anterior and posterior leaflets;

FIGS. 4A and 4B show a mitral valve in plan and schematic sectionalviews where the annulus is dilated and deformed causing mitralregurgitation;

FIGS. 5A and 5B are schematic sectional views of mitral valves withruptured and elongated chordae, respectively, both causing mitralregurgitation;

FIGS. 6A and 6B are plan and schematic sectional views of a mitral valvehaving symptoms of Barlow's disease with excess tissue and irregularlythickened leaflets;

FIGS. 7A and 7B are plan and schematic sectional views of a mitral valvehaving symptoms of fibro-elastic deficiency with thinned leaflets;

FIGS. 8A and 8B are plan and schematic sectional views of a mitral valvehaving symptoms of Marfan's disease with excess and thin tissue andelongated chordae;

FIGS. 9A-9D illustrate Carpentier's functional classification of mitralregurgitation, namely: Type I—normal leaflet motion, though with annulardilatation; Type II—increased leaflet motion (leaflet prolapse); TypeIIIa—restricted leaflet motion in systole; and Type IIIb restrictedleaflet motion in diastole;

FIG. 10A is a surgeon's or plan view of a mitral valve having a deformedannulus leading to regurgitation;

FIG. 10B shows correction of the deformed mitral valve annulus using asuitable prosthetic annuloplasty ring of the prior art to restore normalapposition of the leaflets;

FIGS. 11A-11C are schematic sectional views of a mitral valve correctedwith an annuloplasty ring of the prior art as shown in FIG. 10B throughthe diastolic/systolic phases and showing regurgitation resulting fromsystolic anterior motion (SAM) of the anterior leaflet due to excesstissue;

FIGS. 12A and 12B are plan and posterior elevational views,respectively, of a Carpentier-Edwards Classic® annuloplasty ring of theprior art;

FIGS. 13A and 13B are plan and posterior elevational views,respectively, of a Carpentier-Edwards Physio® annuloplasty ring of theprior art;

FIGS. 14A and 14B are plan and posterior elevational views,respectively, of a Carpentier-McCarthy-Adams IMR ETlogix® annuloplastyring of the prior art;

FIGS. 15A-15C are surgeon's views of a mitral valve: 15A) in Barlow'sdisease displaying excess valvular tissue, 15B) showing an irregularline of leaflet closure and systolic anterior motion (SAM) aftercorrection with a prior art annuloplasty ring, and 15C) after free endsof the prior art annuloplasty ring have been bent outward to restore adesired line of leaflet coaptation;

FIGS. 16A and 60B are plan and posterior sectional views of an exemplaryannuloplasty ring;

FIGS. 17A/17B, 18A/18B, and 19A/19B show plan and side views of severaldifferent sized rings;

FIG. 20 is a graph showing the changing minor/major axis proportion ofthe exemplary ring;

FIGS. 21A-21C show cutaway plan and sectional views of an exemplaryring; ← Dr. Carpentier, please see the discussion of FIGS. 21A-21C atparagraphs 87-88, where we tried to include the description youprovided. We talked about the smooth inflow side and stepped outflowside of the sewing ring. If you'd like to supplement the discussion,please add it to those paragraphs.

FIGS. 22A-22C illustrate the effects of application of opposite inwardforces across different oblique planes on the exemplary rings;

FIGS. 23A-23D illustrate an exemplary sequence of geometric constructionof a mitral annuloplasty ring primarily defined by four circular arcs,one for each of the anterior, posterior, and two side segments, andconnected at points of tangency;

FIG. 24 illustrates a completed exemplary geometric construction of amitral annuloplasty ring showing primary dimensions;

FIGS. 25A-25C are several views of an alternative annuloplasty ringhaving an inner ring body and an outer suture-permeable cover; and

FIG. 26 is a plan view of the inner dimension of the ring body of thealternative ring of FIGS. 25A-25C.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

A novel set of annuloplasty rings for correcting pathologies resultingin mitral regurgitation is provided. In one embodiment, a set of ringsis structurally defined by ring bodies wherein the proportional shapesof the ring bodies change with increasing identified orifice sizes ofthe rings in the set. Each ring includes a ring body and an outercovering of suture-permeable material, typically silicone covered withfabric. The set of rings is formed of ring bodies that will initiallyresist deformation when subjected to the stress imparted thereon by themitral valve annulus, i.e. the shapes of the ring bodies are formedduring manufacture and are not easily manipulated. Examples include ringbodies formed of titanium or Eligiloy® bands. In the absolute sense,however, even these relatively rigid ring bodies can be deformed withthe application of sufficient force. However, a ring that is “able toresist deformation” or is “generally rigid” is not a fully flexiblering. Indeed, in a preferred embodiment the rings described herein donot possess the same degree of flexibility in every cross-plane. Adesirable configuration consists of a ring that is more flexible acrossthe antero-posterior dimension (the minor axis) than it in a cross planetransverse to the antero-posterior dimension (the major axis). Thispreserves the remodeling effect while permitting some flexing in theantero-posterior dimension.

A “set of annuloplasty rings” has a specific meaning of a commercial setof rings that are intentionally manufactured to have differingproportional sizes or shapes. That is, the set of rings would bemarketed and/or sold together, and the definition of a set of ringsexcludes the forcible deformation of an individual ring by a surgeon tochange its proportional shape relative to other rings in that particularcommercial set. That would not be a “set” of rings with differingproportions, but instead a set of rings of the same proportion that havebeen sold and modified after the fact. Also, a “set of annuloplastyrings” excludes the random combination of rings of different sizes fromdifferent lines or sets of rings. For instance, a set ofCarpentier-Edwards Physio® semi-flexible annuloplasty rings describedabove are available in sizes 24-40 mm from Edwards Lifesciences ofIrvine, Calif. Each of these rings has the same size proportions acrossthe commercial set.

FIGS. 11A-11C are schematic sectional views of a mitral valve correctedwith an annuloplasty ring of the prior art, such as a Carpentier-EdwardsPhysio® semi-flexible annuloplasty ring shown in FIG. 10B. FIG. 11Ashows the diastolic phase in the left ventricle expands to pull blood inthrough the mitral valve. FIG. 11B illustrates the positions of theanterior leaflet (AL) and posterior leaflet (PL) at the initiation ofthe systolic phase when the left ventricle contracts to force bloodthrough the aortic valve. Because of Systolic Anterior Motion (SAM), andbecause excess tissue of the posterior leaflet (PL) pushes the anteriorleaflet (AL) toward the left ventricular outflow tract, leafletcoaptation is impaired causing residual leakage, or regurgitation.Therefore, the ostensible correction of one mitral condition sometimescreates another problem.

As mentioned above, various annuloplasty rings of the prior art areknown for providing the correction to normal mitral annulus shape. Forinstance, FIGS. 12A and 12B are plan and posterior elevational views,respectively, of a rigid Carpentier-Edwards Classic® annuloplasty ring.FIGS. 13A and 13B show a Carpentier-Edwards Physio® semi-rigidannuloplasty ring. The Physio® ring includes a relatively rigid anteriorside and a gradually more flexible posterior side, to provide someflexibility to the ring while preserving its annular remodeling effect.Finally, FIGS. 14A and 14B illustrate a Carpentier-McCarthy-Adams IMRETlogix® annuloplasty ring, which is relatively rigid around itsasymmetric periphery. In all of these and all known annuloplasty rings,the differently sized rings in a set of marketed rings all have the samesize and shape proportions, as well as the same relative flexibilitiesfor those types of rings. The present invention is an improvement onthese and other annuloplasty ring designs, including those disclosed inU.S. Pat. Nos. 4,055,861 and 5,104,407 both to Lam, Nguyen, andCarpentier, and U.S. Patent Publication No. 2005/0131533 to Carpentier,et al., whose disclosures are expressly incorporated herein.

In some instances, annuloplasty rings of the prior art can be modifiedor bent to lessen some of the side-effects described above. FIGS.15A-15C are surgeon's views of a mitral valve having symptoms ofBarlow's disease treated with an open Carpentier-Edwards Classic®annuloplasty ring. One observed result is systolic anterior motion(SAM), as seen in FIG. 15B. The inventor has proposed that in some casesbending the free ends of the annuloplasty ring outwards, as seen in FIG.15C, restores normal apposition of the leaflets. Although this techniqueis sometimes very effective, it is difficult to predict and requiressubjective judgment about how far to bend the ends of the ring. Also,bending the ring may diminish the strength of the device. Furthermore,some rings form continuous peripheries and are not as simple to bend.

Mitral valves remain competent (non-regurgitant) for a long time despitea severely abnormal valve morphology and structure, including withsymptoms of Barlow's disease which creates the most pronounced abnormalvalve morphology. Valve regurgitation occurs only when a leafletdysfunction develops, as categorized by Carpentier in the literature,and as described above with reference to FIGS. 9A-9D. Also, as mentionedabove, attempts to restore the “normal” annulus shape may not improveregurgitation. The inventor has discovered that an efficient valvereconstruction for degenerative valvular diseases involves restoring thepeculiar anatomy of the annulus rather than imposing a normal shapethereto. Stated another way, the shapes of the rings in any set of ringsin accordance with the present invention conform to the shape of thediseased but well-functioning valves. A degenerative dysfunction shouldbe corrected by restoring the peculiar configuration of the degenerativevalve, and not an anatomically “normal” (or non-diseased) configuration.

The present invention therefore encompasses specifically-shaped rings toconform to abnormal mitral annuluses. The particular shapes of theabnormal annuluses can be obtained from morphometric studies byechocardiography, magnetic resonance imaging (MRI), ultrasound, anddirect physical measurements in the operating room. Numerous carefulmeasurements that may be vetted with statistical analysis provide thesurgeon with definitions of annulus shape for different degenerativevalvular diseases, and for different annulus sizes. Indeed, anotheraspect recognized by the present inventor is that the annuluses ofdifferent sized patients often present differently for the samedegenerative valvular disease. The goal in creating specific ring shapesfor all the anticipated sizes is to remodel the annulus and restoreleaflet co-optation without creating SAM. As explained above, it hasbeen found that, contrary to other diseases, a ring annuloplasty fordegenerative valvular disease should restore not the shape of a normalmitral annulus, but the annular shape specific of each type ofdegenerative valve. One goal of the rings defines herein is to select amitral annuloplasty ring with a long or major axis and a short or minoraxis to have a size and shape symmetric about the minor axis and thatpreserves or restores full leaflet mobility. The size and shape of theannuloplasty ring desirably addresses the problems of excess tissue andrelated valve dysfunction commonly seen in degenerative valvulardiseases.

The present invention therefore contemplates a set of rings of differentidentified or labeled sizes each having a structural ring body able toresist deformation when subjected to the stress imparted thereon by themitral valve annulus. Each ring body is arranged around a flow axishaving an upward direction and a downward direction, the downwarddirection corresponding to the direction of blood flow through the valveannulus when the annuloplasty ring is implanted. For different orificesizes, the proportional shapes of the ring bodies in the set change,depending on the particular degenerative valvular disease at issue. Bypredicting the shape of the mitral annulus for that disease and thatannulus size, a set of rings that will match most patients can thereforebe provided. Exemplary ring shapes are shown and described below.

FIGS. 16A and 16B are plan and section views of an exemplaryannuloplasty ring 70 of the present invention. The ring 70 is shown witha fabric covering 72 over a structural interior support or body 74.Typically a suture-permeable interface 76 fills the space between thecovering 72 and interior body 74.

As seen in FIG. 16A, the annuloplasty ring 70 of the present inventioncan be described as having a closed or continuous periphery with ananterior (top) section, a posterior (bottom) section and right and leftsides therebetween. Preferably, all of the sides are generallycurvilinear with no specific demarcations to indicate abrupt transitionstherebetween. Rather, smooth transitional sections between the adjacentsides provide curvilinear connections that give the ring a generallyrounded (e.g., oval) configuration, or more preferably a somewhat D- orkidney-shaped configuration with a relatively straight anterior segmentopposite a curved posterior segment. The kidney-shaped configurationmore accurately mimics the mitral annulus. It should be understood,however, that the aspect of the invention wherein a set of rings isoptimally sized, and more specifically, where the proportional shapes orcharacteristics of each ring changes with the annulus size, may bebeneficial to rings of other shapes and configurations. For instance,changing proportional shapes for different sized rings may be useful forasymmetric rings, three-dimensional rings, discontinuous (C-shaped)rings, tricuspid or ovoid-shaped rings, etc. The present invention thusgenerally provides optimally sized annuloplasty ring sets, though theillustrated application is mitral valve correction.

The exemplary ring 70 in the plan view of FIG. 16A has a minor axisdimension B and a major axis dimension A, and is three-dimensional. FIG.16B shows preferred heights above a datum plane, with the center of theanterior segment rising to a height C and the center of the posteriorsegment rising to a height D, with a desired ratio of C/D>1. Thepreferred ratio of C/D is about 3:1, with the smallest rings rising to aheight C of about 3 mm on the anterior side and the largest to about 6mm, potentially up to 8 mm. The height D on the posterior side rises toabout 2 mm, potentially up to 3 mm.

Table I below indicates exemplary values of the heights above a datumplane of the anterior segment C and the center of the posterior segmentD of an exemplary ring 70. These magnitudes may vary by ±20%, whilemaintaining the approximate relative sizes across the ring set.

TABLE I Labeled ring size Anterior Height, C Posterior Height, D (mm)(mm) (mm) 24 3.0 1.0 26 3.3 1.0 28 3.6 1.2 30 4.0 1.2 32 4.4 1.4 34 4.81.4 36 5.2 1.6 38 5.6 1.8 40 6.0 2.0

It should be noted that the ratio of the heights of the opposite sides,anterior and posterior, changes with increasing orifice size. Thesmallest ring, 24 mm, has a C/D ratio of 3.0/1.0, or about 3.0, while amid-size ring, 34 mm, has a C/D ratio of 4.8/1.4, or about 3.4. The C/Dratio thus varies as the ring size increases. Although this ratio changemay appear slight, the inventors contemplate more significant C/D ratiochanges for certain degenerative conditions. The trend may be such thatthe larger rings have a greater or lesser C/D ratio than smaller rings,or in other words the anterior height relative to the posterior heightbecomes greater or lesser in larger rings. Therefore, not only can theproportional plan view shape of the rings change, but thethree-dimensional shape of the rings can also change.

Two general formulas for anterior and posterior heights are given belowfor the exemplary ring sets, though those of skill in the art will seethat not all rings heights in Table I comport with these formulas.Therefore, they should be viewed as guides only.

C=(A−10)/5

D=(C−2)/2

The interior body 74 is desirably made of material(s) that are“generally rigid” and will initially resist deformation when subjectedto the stress imparted thereon by the mitral valve annulus of anoperating human heart. In this sense, “deformation” means substantialpermanent deformation from a predetermined or manufactured shape; theopposite concept of which is “elastic” meaning the ability to recoverthe ring shape in the absence of an external force. A number of“generally rigid” materials can be utilized that will perform thisfunction, including various bio-compatible polymers and metals and/oralloys. Certain polyesters that resist deformation and also rapiddegradation within the body may be used (a material that degrades slowlymay provide the required initial support). In a preferred embodiment, atleast an inner core or body of the annuloplasty ring of the presentinvention is made of a suitable metal, such as titanium or its alloys,or ELGILOY made by Elgiloy, L.P. of Elgin, Ill., U.S.A. The core or ringbody may be one piece, or may include a plurality of concentric orotherwise cooperating elements.

The interface 76 is a molded silicone tube or band around the ring body74 and the fabric covering on the exterior of the ring is desirablyDacron (polyethylene terephthalate). The tubular fabric covering aroundthe silicone sleeve provide an interface for securing the annuloplastyring to the mitral annulus, although other interfaces are contemplated.For example, rings having outward hooks or barbs are known in the art.

Typical mitral annuloplasty support rings have a long or major dimensionand a short or minor dimension, with the conventional ratio of the minorto major dimension being at most 3:4 (75%), and typically less. Theannuloplasty rings described here have a gradually increasing minor axisdimension B to major axis dimension A ratio. The dimensions A and B aremeasured to the inner edge of the body 74. This increasing dimensionalratio provides rings in the larger sizes that are more suited tocorrecting conditions where the mitral leaflet is floppy, such as theconditions shown in FIGS. 2-4, and in general for Type II pathologiesseen in FIG. 9B. Typically, larger patients exhibit this generalcondition leading to regurgitation as opposed to smaller patients, forwhich rings having more conventional B/A ratios are more appropriate.

Table II below indicates the approximate values of the major and minoraxes as measured across the interior of an exemplary ring body 74(dimensions A and B, respectively, in FIG. 16A) for nine differentexemplary rings, and also gives the ratios of the minor axis to themajor axis. Again, these values may vary by ±20%, while maintaining theapproximate relative sizes across the ring set. The rings have nominalorifice sizes in even millimeter increments (e.g., 24 mm, 26 mm, etc.)as measured across the major axes. Such rings will have distinctpackaging so as to be labeled with the particular size.

TABLE II Labeled ring size Major axis Minor Axis (mm) (mm) (mm) B/Aratio 24 24.0 16.5 0.6875 26 26.0 17.7 0.6808 28 28.0 18.9 0.6750 3030.0 20.4 0.6800 32 32.0 21.9 0.6844 34 34.0 23.5 0.6912 36 36.0 25.50.7083 38 38.0 27.2 0.7158 40 40.0 28.7 0.7175

To clarify, an exemplary 40 mm ring will have a major axis dimension Aof about 40 mm and a minor axis dimension B of about 28.7 mm. The B/Aratio of the larger rings, such as 34 mm or larger, preferably rangesbetween 0.69 and 0.73, and the approximation “about” encompasses ringsizes within that ratio range. For instance, a 40 mm ring that has amajor axis dimension A of exactly 40 mm, may have a minor axis dimensionB of between 27.6 mm (0.69×40) and 29.2 mm (0.73×40). Further exemplarydimensions will be provided below for sets of rings in accordance withthe present invention. Certain curvatures around the ring in plan vieware particularly shaped to correct for degenerative valvular diseases.

FIGS. 17A-19B show plan and side views of several embodiments ofdifferent sized rings for comparison. FIGS. 17A and 17B show a 24 mmring, FIGS. 18A and 18B show a 32 mm ring, and FIGS. 19A and 19B show a40 mm ring. The overall “look” of the rings are the same though the B/Aratio increases in the larger rings. That is, the larger rings as inFIG. 19A are more circular to accommodate valves affected by Barlow'sdisease which typically have a greater orifice size. Indeed, Barlow's,fibro-elastic deficiency, and Marfan's disease all tend to enlarge theorifice of larger annuluses to be more circular. Conversely, the smallerrings as in FIG. 17A have a more pronounced D shape to accommodatevalves affected by fibroelastic deficiency, which often affects valvesof smaller sizes.

From a surgical point of view, whatever the type of degenerativevalvular disease, ring selection can be based on measurement of theintercommissural distance and the height of the anterior leaflet. Asmentioned above, the particular shapes of the abnormal annuluses can beobtained from morphometric studies by echocardiography, magneticresonance imaging (MRI), ultrasound, and direct physical measurements inthe operating room. The complex morphology of the degenerative mitralvalve renders particularly difficult the selection of the ring.Therefore, in addition to the classic measurements for determining ringsize—the intercommissural dimension and the surface area of the anteriorleaflet—at least two other measurements may be useful: the height of theanterior leaflet (AL) and the height of the three segments P1, P2, P3 ofthe posterior leaflet (PL). The antero-posterior diameter of the ringshould, preferably, be approximately equivalent to the height of theanterior leaflet measured by appropriate sizers.

FIG. 20 is a graph showing the changing minor/major axis proportion ofthe exemplary ring along line 80 as compared with a line 82 for a priorart ring, the Carpentier-Edwards Physio® ring. This shows the divergenceof the ring proportions starting at around the 32 mm ring. Desirably,the B/A ratio increases at least 10% from the smallest ring to thelargest ring, and in the exemplary embodiment B/A increases by about 4%(0.6875/0.7175) from the 24 mm ring to the 40 mm ring.

FIGS. 21A-21C show cutaway plan and sectional views showing theconstruction of an exemplary ring 100 of the present invention. In apreferred embodiment, the annuloplasty ring 100 is defined by aconcentric wire band structure 102 resulting in selectively flexibility.Layers are formed by wrapping a single band to form a spiral structure,or by layering individual bands upon one another, with one of such bandsshown at 104. Preferably a plurality of individual bands 104 are layeredupon one another to form the multi-layered structure 102. The bands 104are formed from a biocompatible, anti-magnetic material such asElgiloy®.

This band structure is held within a fabric sheath 110 in a mannersimilar to the previously described embodiments. The fabric sheath 110is a knitted structure with optimal tension to avoid irregularities andwrinkles. Marks are typically placed on the fabric to clearly identifythe commissures, and a circular mark provided (e.g., with a greensuture) to delineate the enhanced sewing cuff. The longitudinal rigidityof the core, the regular contour and optimal profile of the siliconeband together with the extreme thinness and optimal stretching of thefabric together comprise a unique combination of structural featureswhich minimizes platelet deposit, fibrous proliferation, and thrombusformation.

Preferably, in order to reduce friction between adjacent bands 104, anelastomeric material such as silicone is placed between the individualband layers, such as seen at 112 in FIG. 17. Selective flexibility isprovided by movement of the band leaders separated by the siliconematerial layers therebetween.

The elastomeric material 112 also surrounds the outside of the bandstructure 102. As seen in FIGS. 21B and 21C, the fabric sheath 110bulges outwards along one side, with this bulge or flange, as seen at120, filled with the elastomeric material 112. This bulge 120 ispreferentially positioned along the outside of the ring 100. Sutureswill be passed through the bulge 120 which helps prevent them fromcatching between the bands 104, or otherwise striking the structuralcore of the ring. The elastic material 112 desirably comprises a moldedsilicone band that defines the bulge 120. In FIGS. 21B and 21C the upperor inflow side 122 is to the left atrium, while the lower or outflowside 124 is toward the ventricle. The inflow side is thus curved, smoothand streamlined to minimize platelet deposits and fibrous proliferation,while the outflow side has a smooth stepped surface to provide a wellidentified area for placement of sutures used to secure the ring to theannulus. Desirably, a circular green suture line 126 delineating theunderside of the enhanced sewing cuff or bulge 112 also maintainstension in the fabric sheath 110, thus eliminating wrinkles and possiblethrombus formation and fibrous proliferation. The green suture line 126acts as an aid to help facilitate implant of the ring by demarking forthe surgeon a boundary on the ring within which sutures should not bepassed. The line 126 therefore helps prevent the surgeon from snaggingthe band structure 102 with an implant suture.

As seen in FIG. 21C, the total axial height H of the exemplary ring 100is about 3 mm, while the total radial width W is about 3 mm. With such aring 100, the bulge 120 has a height h of about 50% of the total heightH, while the width w of the main portion of the ring is about 70% of thetotal width W, meaning the bulge 120 has a width of about 30% of thetotal width W. In the exemplary embodiment, the bulge 120 has an axialheight h of about 1.5 mm and a radial width of about 0.8 mm.

The radial cross-sectional profile of the rings is preferably reduced asmuch as possible to minimize turbulence and adverse consequences such asthrombus formation and fibrous proliferation. Consequently, in theembodiment the maximum cross-section of the wire band structure 102 islimited to about 1.5 mm width and 2.5 mm height, ±10%.

The flexibility of the band structure 102 and thus the ring 100 variesin a direction away from an anterior side. That is, preferably a ratioof the stiffness of the band structure 102, as defined by the bands 104in the longitudinal direction over the stiffness in the lateraldirection is from about 1.15 to about 2.77. In the illustratedembodiment, the band structure 102 includes closely-spaced bands 104 atthe anterior side seen in FIG. 21B, with less bands that are also spacedapart around the posterior side, as seen in FIG. 21C. That is, theanterior side of the ring 100 is substantially straighter and more rigidthan the posterior side. One way to increase rigidity of the anteriorside is to crimp or spot weld the bands together on that side.Similarly, the actual height of the bands may be greater on the anteriorside. Desirably, the axial height of the bands ranges between 1.5-2.5mm. More detail of similar structure and alternatives thereto can beseen in U.S. Pat. No. 5,104,407.

The precise number of band windings forming the body element isdependent upon the materials used for the bands 104, as well as thethickness of the individual band layers forming the multi-layeredstructure. Generally, from about 1 to about 6 layers or individual bands104 are used, while the thickness of each layer or band 104 may be fromabout 0.002 to about 0.008 of an inch.

The use of a layered structure prepared by the overlaying of one or morebands 104 ensures that the force applied against the prosthesis 100 isbetter distributed over the various layers of the bands. The result is amore even application of load to the entire ring prosthesis 100 in boththe longitudinal and lateral directions. Additionally, the layered bandstructure 102 provides a unique selective flexibility which ispredominant in the anterior-posterior (AP) dimension than in thetransverse dimension. In other words, the layered band structure 102 hasvarying degrees of stiffness across different oblique planes as measuredby force per unit deflection.

FIGS. 22A-22C illustrate the effects of application of opposite inwardforces across different oblique planes on the exemplary rings. The mostdeformation, and thus the most flexibility in the ring, is seen in FIG.22A from application of the squeezing force along the antero-posteriorplane. The ring is shown in solid line deformed from a dashed outline ofthe original shape. FIG. 22B illustrates the application of thesqueezing force in an oblique plane between the major and minor axes.The ring still deforms, but not quite as much. Finally, FIG. 22C showsthe minimum amount of deformation upon application of opposite inwardforces generally along the large dimension or major axis of the ring.Because the anterior side (top side in the figures) is more rigid, itlimits the amount of bending of the ring from imposition of such aforce. Providing maximum stiffness in the transverse plane (along themajor axis) ensures adequate remodeling of the valve annulus.

For large ring sizes, which may be more circular as described above, theselective flexibility may be increased to reduce the stress on thedegenerative annulus and, therefore, minimize the incidence of ringdehiscence. Thus, the relative flexibility around each ring across a setof rings may differ. Stated generally, rings across a set ofdifferently-sized rings may differ in their proportional size, shape, orphysically characteristics such as flexibility. For example, in smallerrings the posterior side may be more flexible than the anterior side, asin the prior art, but for larger ring sizes in the same set of rings theposterior flexibility may be even greater relative to the anterior side.The aforementioned structure can be modified to change the flexibilityaround the ring. More particularly, the axial height of the bandsdetermines their flexibility at any one point, and thus the height ofthe bands on the posterior side can be less than on the anterior sidefor greater flexibility on the posterior side. In relative terms, theaxial height of the bands on the posterior side of larger rings may beless than the axial height on the anterior side for smaller rings. Atthe same time, the axially-oriented band structure provides enoughtransverse rigidity to avoid plication of the ring.

The stiffness of the rings of the present invention may be calculated asa gram force (gf) required to deflect the ring 1 mm. One exemplary rangeof stiffness in the antero-posterior direction is about 44.27-75.33gf/mm, depending on the size of the ring. A 20% variance on this rangeis contemplated.

The rings described herein can be designed using geometric andmathematical formula. FIGS. 23A-23D and 24 illustrate one exemplarygeometric construction of a mitral annuloplasty ring primarily definedby four circular arcs, one for each of the anterior, posterior, and twoside segments, and connected at points of tangency.

First, as seen in FIG. 23A, a horizontal line segment a1-a2 is drawnhaving a length A (see FIG. 24) of the major axis of the ring beingconstructed. Therefore, for a 40 mm ring, the length A of line segmenta1-a2 is 40 mm. The point b1 is located at the center of line segmenta1-a2. A vertical line segment b1-b2 is then drawn having a length B′(see FIG. 24) corresponding to the formula:

B′=(0.3125·A)−0.8 (all dimensions in mm)

Still with reference to FIG. 23A, congruent triangles b1-b2-a1 andb1-b2-a2 are completed by drawing the hypotenuses along line segmentsb2-a1 and b2-a2. The point b3 is located by extending the vertical linesegment b1-b2 downward so that the length B (see FIG. 24) of linesegment b2-b3 corresponds to the value shown in table II for thecorresponding ring size A.

FIG. 23B shows a central circle c1 drawn with its center on point b1 andhaving a radius that extends orthogonally to the two hypotenusesextending along line segments b2-a1 and b2-a2. Another way to look atthis is that circle c1 is tangent to both line segments b2-a1 and b2-a2.Next, FIG. 23C shows the construction of identical side circles c2 andc3. Side circle c2 includes points a1 and b1, while side circle c3includes points a2 and b1. The three circles c1, c2, c3 thus divide linesegment a1-a2 into four equal segments with at least one half-circleextending along each segment. Another way to state this is that circlesc1, c2, c3 are congruent circles whose centers are equidistantly spacedalong the major axis line segment a1-a2. Also, the two outer circles c2,c3 include points a1 and a2, respectively, and both including centerpoint b1.

Now with reference to FIG. 23D, large arcs T1-T4 and T2-T3 are drawnacross the top and bottom of the geometric form, respectively. Each ofthese arcs is tangent at both ends to the side circles c2 and c3 andincludes, respectively, points b2 and b3. That is, arc T1-T4 is tangentat both ends to the outer circles c2 and c3 and includes point b2, andarc T2-T3 is tangent at both ends to the outer circles c2 and c3 andincludes point b3.

As seen in FIG. 24, the geometric shape thus formed provides an outlinefor the inner dimension of each of the rings in the exemplary set ofrings. Specifically, the geometric shape is formed at the sides by arcsT1-T2 and T3-T4 along circles c2 and c3, and at the top and bottom bythe large arcs T1-T4 and T2-T3 that are tangent to those circles. Thefinal annuloplasty ring periphery is defined by the four circular arcsT1-T2 and T3-T4, and T1-T4 and T2-T3.

FIG. 24 also illustrates several dimensions r1, r2, r3 from the centralpoint b1 to the posterior side of the ring. Although these dimensionsappear as radii, each is not technically a radius but instead an obliquedimension extending from the geometric central point b1 of the ringtowards the posterior segment of the ring. Because the arc T2-T3 drawnon the posterior side is not centered at b1, the dimensions r1, r2, r3differ. Desirably, a ring of the present invention is constructed takinginto account a number of measurements of an annulus characteristic ofthe disease that afflicts the valve being treated, including at least 3,and preferably 5, oblique dimensions extending from the geometric centerof the annulus to the posterior aspect of the annulus. Following thering design methods described herein will result in a ring for each sizethat has similar if not identical oblique dimensions, as shown at r1,r2, r3 in FIG. 24.

Table III below provides values for some of the dimensions illustratedin FIG. 24. The major axis dimensions A and B have been listed above inTable II, while the anterior and posterior heights of the exemplary ringwere provided in Table I.

TABLE III Labeled ring size B′ r1 r2 r3 (mm) (mm) (mm) (mm) (mm) 24 6.710.8 10.1 9.8 26 7.3 11.8 10.7 10.4 28 7.9 12.7 11.4 10.9 30 8.6 13.812.3 11.8 32 9.2 14.9 13.2 12.7 34 9.8 16.0 14.3 13.7 36 10.4 17.3 15.615.1 38 11.1 18.9 17.0 16.1 40 11.7 19.1 17.9 17.5

FIGS. 25A-25C are several views of an alternative annuloplasty ring 150having an inner ring body 152 and an outer suture-permeable cover 154.The inner ring body 152 comprises a series of concentric bands 156, asdescribed above. The cross-section of the ring 150 in FIG. 25C isdesirably the same as described above, with an inflow side 160 that iscurved, smooth and streamlined to minimize platelet deposits and fibrousproliferation, and an outflow side 162 with a smooth stepped surface toprovide a well identified area for placement of sutures used to securethe ring to the annulus.

FIG. 26 is a plan view of an inner band 156 of the ring body 152 ofFIGS. 25A-25C. The concentric bands radiate outward from the inner band,and are generally proportionally congruent. Four different radii r₁, r₂,r₃, and r₄ are indicated around the periphery, meaning there are six (6)different circular arc segments around the ring periphery (arcs withradii r₂ and r₃ being on both sides). In contrast to the earlierembodiment, however, some of the radii are centered off the minor axis.In an exemplary embodiment, the inner band 156 is for a 24 mm ring andthe dimensions in mm are: A=24.0, B=16.6, C=6.0, D=5.7, E=13.6, F=11.80,G=1.5, r₁=66.04, r₂=12.24, r₃=5.77 and r₄=5.54. The small crosses (x)around the band periphery mark the boundary between arc segments, andthe dimensions D, F and G indicate locations of those boundaries.

Table IV below indicates the approximate values of the major and minoraxes (A, B) of the exemplary inner band 156 of the ring body 152 ofFIGS. 25A-25C, as well as exemplary dimensions and curvatures, for ninedifferent exemplary rings. As stated above for other embodiments, thesevalues may vary while maintaining the approximate relative sizes acrossthe ring set. The rings have orifice sizes in even millimeter increments(e.g., 24 mm, 26 mm, etc.) as measured across the major axes.

TABLE IV Ring size A B B/A r₁ r₂ r₃ r₄ (mm) (mm) (mm) ratio (inch)(inch) (inch) (inch) 24 24.0 16.5 0.6875 2.60 0.23 0.22 0.48 26 26.017.7 0.6808 2.58 0.25 0.27 0.54 28 28.0 18.9 0.6750 2.55 0.27 0.32 0.6130 30.0 20.4 0.6800 2.53 0.28 0.37 0.66 32 32.0 21.9 0.6844 2.50 0.300.42 0.73 34 34.0 23.5 0.6912 2.40 0.35 0.47 0.79 36 36.0 25.5 0.70832.30 0.40 0.49 0.82 38 38.0 27.2 0.7158 2.20 0.45 0.52 1.03 40 40.0 29.20.7300 2.10 0.38 0.59 0.83

While the invention has been described in its preferred embodiments, itis to be understood that the words which have been used are words ofdescription and not of limitation. Therefore, changes may be made withinthe appended claims without departing from the true scope of theinvention.

1. An annuloplasty ring selected from a set of annuloplasty rings forcorrecting a heart valve annulus, the set of annuloplasty ringscomprising: a set of rings each having a ring body able to resistdeformation when subjected to the stress imparted thereon by the valveannulus and arranged around a flow axis having an upward direction and adownward direction, the downward direction corresponding to thedirection of blood flow through the valve annulus when the annuloplastyring is implanted, each ring having an identified orifice size; andwherein the proportional shapes of the ring bodies change withincreasing orifice sizes of the rings in the set.
 2. The annuloplastyring of claim 1, wherein the annuloplasty rings are configured forimplant in the mitral position and smaller rings in the set generallydefine a D-shape in plan view with a relatively straight anteriorsegment opposite a curved posterior segment, and as the orifice sizes ofthe rings become larger the D-shape diminishes and becomes generallymore circular.
 3. The annuloplasty ring of claim 2, wherein the ringbodies are three-dimensional with the center of the anterior segmentrising to a height C and the center of the posterior segment rising toheight D above a common datum plane, wherein the ratio C/D>1.
 4. Theannuloplasty ring of claim 1, wherein the ring bodies arethree-dimensional with opposite sides of the ring curving upward above adatum plane, and wherein the change in proportional shapes of the ringbodies is a change in the ratio of the heights of the opposite sides. 5.The annuloplasty ring of claim 1, wherein the annuloplasty rings areconfigured for implant in the mitral position and have an anteriorsegment opposite a posterior segment, and wherein the ring bodies arethree-dimensional with the center of the anterior segment rising to aheight C and the center of the posterior segment rising to height Dabove a common datum plane, wherein the ratio C/D>1.
 6. The annuloplastyring of claim 5, wherein the ratio C/D is about 3:1.
 7. The annuloplastyring of claim 5, wherein the height C of the anterior segment rises upto at least 6 mm above the common datum plane.
 8. The annuloplasty ringof claim 1, wherein the proportional shapes of the ring bodies change tocomply with predicted shapes of a particular valvular disease fordifferent annulus orifice sizes.
 9. The annuloplasty ring of claim 8,wherein the annuloplasty rings are configured for implant in the mitralposition and have an anterior segment opposite a posterior segment, andthe valvular disease is Barlow's valve.
 10. The annuloplasty ring ofclaim 8, wherein the predicted shapes of a particular valvular diseasehave been calculated from echocardiographic and intraoperativemeasurements.
 11. The annuloplasty ring of claim 10, wherein theannuloplasty rings are configured for implant in the mitral position andhave an anterior segment opposite a posterior segment, and wherein themeasurements include transverse diameter, antero-posterior diameter, andat least three oblique dimensions extending from the geometric center ofthe annulus to the posterior aspect of the annulus.
 12. The annuloplastyring of claim 1, wherein the annuloplasty rings are configured forimplant in the tricuspid position.
 13. A mitral annuloplasty ringselected from a set of mitral annuloplasty rings for correcting a mitralheart valve annulus, the set of mitral annuloplasty rings comprising: aset of rings each having a ring body able to resist deformation whensubjected to the stress imparted thereon by the mitral valve annulus andarranged around a flow axis having an upward direction and a downwarddirection, the downward direction corresponding to the direction ofblood flow through the mitral valve annulus when the annuloplasty ringis implanted, each ring body in plan view defining a major axis A and aminor axis B extending across from an anterior segment to a posteriorsegment, and each ring having an identified orifice size; and whereinthe proportional shapes of the ring bodies change to comply withpredicted shapes of degenerative valvular disease for different annulusorifice sizes.
 14. The mitral annuloplasty ring of claim 13, wherein theplan view shape of the ring bodies is a more pronounced D-shape forsmaller ring orifice sizes and becomes gradually more circular as theorifice size increases.
 15. The mitral annuloplasty ring of claim 13,wherein the ratio B/A for each ring body changes with increasing ringorifice size.
 16. The mitral annuloplasty ring of claim 13, wherein thering bodies are three-dimensional with the center of the anteriorsegment rising to a height C and the center of the posterior segmentrising to height D above a common datum plane, and wherein the ratio C/Dchanges with increasing ring orifice size.
 17. The mitral annuloplastyring of claim 13, wherein the ring bodies have varying flexibilityaround their peripheries, and wherein the relative flexibility betweenthe anterior segment and the posterior segment changes with increasingring orifice size.
 18. The mitral annuloplasty ring of claim 13, whereineach ring further includes a suture-permeable covering over the ringbody, and the covering has a smooth relatively flat inflow side and astepped outflow side.
 19. A mitral annuloplasty ring selected from a setof mitral annuloplasty rings for correcting a mitral heart valveannulus, the set of mitral annuloplasty rings comprising: a set of ringseach having a ring body able to resist deformation when subjected to thestress imparted thereon by the mitral valve annulus and arranged arounda flow axis having an upward direction and a downward direction, thedownward direction corresponding to the direction of blood flow throughthe mitral valve annulus when the annuloplasty ring is implanted, eachring body in plan view defining a major axis A and a minor axis Bextending across from an anterior segment to a posterior segment, andeach ring having an identified orifice size; and wherein the ratio B/Afor each ring body changes with increasing ring orifice size.
 20. Themitral annuloplasty ring of claim 19, wherein the ring bodies aregenerally D-shaped in plan view with a relatively straight anteriorsegment opposite a curved posterior segment, and wherein the shape ofthe ring bodies is a more pronounced D-shape for smaller rings andbecomes gradually more circular with increasing ring orifice size. 21.The mitral annuloplasty ring of claim 19, wherein the ring bodies arethree-dimensional with the center of the anterior segment rising to aheight C and the center of the posterior segment rising to height Dabove a common datum plane, and wherein the ratio C/D changes withincreasing ring orifice size.
 22. The mitral annuloplasty ring of claim19, wherein each ring further includes a suture-permeable covering overthe ring body, and the covering has a smooth relatively flat inflow sideand a stepped outflow side.
 23. The mitral annuloplasty ring of claim19, wherein the ring bodies each define a continuous periphery.
 24. Themitral annuloplasty ring of claim 19, wherein the ring bodies eachdefine a discontinuous periphery.